NCT01451398

Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Prandial Technosphere® Insulin Inhalation Powder Versus Technosphere Inhalation Powder in Insulin Naïve Subjects With Type 2 Diabetes Mellitus Poorly Controlled With Oral Antidiabetic Agents Over a 24 Week Treatment Period

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Technosphere® Insulin	Technosphere® Insulin Inhalation Powder
DRUG	Technosphere Powder	Placebo Comparator

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-06-01
• Completion: 2013-07-01
• First posted: 2011-10-13
• Last updated: 2014-10-17
• Results posted: 2014-10-17

Locations

76 sites across 4 countries: United States, Brazil, Russia, Ukraine